SHARP

CompletedPhase 2Results posted

Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer's Disease

Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for AD: "Statins in Healthy, At-Risk Adults: Impact on Amyloid and Regional Perfusion (SHARP)" Study

Lead sponsor

University of Wisconsin, Madison

Asset

Simvastatin

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MRI contraindications excluded

Primary endpoint

•Changes in Cerebrospinal Fluid (CSF) Beta-amyloid-42 Levels Compared

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID2015-0038

Secondary IDH-2008-0275Old IRB Number

Secondary IDH-2009-0030Old IRB Number

NCT IDNCT00939822

NihR01AG031790-01A1

Timeline

Milestones

Study start2009-03actual (month precision)

Study first posted2009-07-15estimated

Primary completion2013-09actual (month precision)

Study completion2013-09actual (month precision)

Last update posted2019-08-09actual

Results first posted2019-08-09actual

Assets

Drug assets

Simvastatin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age40 Years

Maximum age72 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Parent diagnosed with Alzheimer's disease

•Age 40-72

Exclusion criteria

•Active liver disease

•History of adverse reaction to statins

•Contraindication to lumbar puncture

•Elevated creatine kinase and creatinine lab values

•Use of medications known to interact with statins

•History of dementia or mild cognitive impairment

•Currently pregnant or planning to become pregnant

•Use of large quantities of grapefruit juice (more than 1 quart per day)

•Contraindications to MRI (for MRI sub-study)

•Currently on cholesterol-lowering medication or use in past 4 months

•History of heart attack, heart problems, stroke and/or diabetes

•Drinking more than a quart of grapefruit juice per day

•Metal implants, or metal debris in body (MRI)

•List of medications that interact with simvastatin

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Amyloid biomarkers

Tau biomarkers

Amyloid biomarkers

6 endpoints

Primary/protocol endpoint

Changes in Cerebrospinal Fluid (CSF) Beta-amyloid-42 Levels Compared to Baseline as Measured by xMAP

Time frame:Baseline and 18 months

change from baseline, improvement

Primary/registry result

Changes in Cerebrospinal Fluid (CSF) Beta-amyloid-42 Levels Compared to Baseline as Measured by xMAP

Time frame:Baseline and 18 months

change from baseline, improvement

Posted result

Group	Value (mean), ratio	Reported bounds
Simvastatinn=39 Participants	1.01	-0.96 - 1.07
Placebon=40 Participants	0.98	-0.95 - 1.02

Secondary/protocol endpoint

Changes in CSF Beta-amyloid-40 Levels as Measured by xMAP (Multi-Analyte Profiling) )

Time frame:Baseline and 18 months

change from baseline, improvement

Secondary/protocol endpoint

Changes in CSF Soluble Alpha Precursor Proteins (sAPP-alpha) and Soluble Beta Precursor Proteins (sAPP-beta) as Measured by Duplex

Time frame:Baseline and 18 months

ratio, descriptive

Secondary/registry result

Changes in CSF Beta-amyloid-40 Levels as Measured by xMAP (Multi-Analyte Profiling) )

Time frame:Baseline and 18 months

change from baseline, improvement

Posted result

Group	Value (mean), ratio	Reported bounds
Simvastatinn=39 Participants	1.03	-0.99 - 1.07
Placebon=40 Participants	0.98	-0.94 - 1.01

Secondary/registry result

Changes in CSF Soluble Alpha Precursor Proteins (sAPP-alpha) and Soluble Beta Precursor Proteins (sAPP-beta) as Measured by Duplex

Time frame:Baseline and 18 months

ratio, descriptive

Posted result

Group	Value (mean), ratio	Reported bounds
SimvastatinsAPP-alphan=39 Participants	0.96	-0.92 - 1.00
sAPP-betan=39 Participants	0.98	-0.93 - 1.02
PlacebosAPP-alphan=40 Participants	1.03	-0.97 - 1.09
sAPP-betan=40 Participants	1.00	-0.97 - 1.04

Tau biomarkers

2 endpoints

Secondary/protocol endpoint

Changes in CSF Total Tau (T-tau) and Phosphorylated Tau (P-tau) as Measured by xMAP

Time frame:Baseline and 18 months

ratio, descriptive

Secondary/registry result

Changes in CSF Total Tau (T-tau) and Phosphorylated Tau (P-tau) as Measured by xMAP

Time frame:Baseline and 18 months

ratio, descriptive

Posted result

Group	Value (mean), ratio	Reported bounds
SimvastatinTotal taun=39 Participants	1.01	-0.97 - 1.05
Phosphorylated taun=39 Participants	1.16	-0.90 - 1.42
PlaceboTotal taun=40 Participants	1.01	-0.98 - 1.05
Phosphorylated taun=40 Participants	1.15	-1.00 - 1.29

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.